ARTICLE | Clinical News

EC145: Additional Phase II data

December 19, 2011 8:00 AM UTC

Endocyte reported data from a supplemental analysis conducted by a blinded independent review committee of the open-label, international Phase II PRECEDENT trial in 149 patients with platinum-resistant ovarian cancer showing that thrice-weekly 2.5 mg IV EC145 every 2 weeks plus 50 mg/m 2 IV Doxil liposomal doxorubicin every 28 days non-significantly improved median PFS, the primary endpoint, vs. Doxil alone (4.2 vs. 2 months, p=0.2235). The combination also non-significantly improved the endpoint in patients with >=1 folate receptor-positive tumor (4 vs. 1.5 months, p=0.1449), but led to a significant improvement in patients with 100% folate receptor-positive tumors (4 vs. 1.5 months, p=0.0498). Previously, the company reported that an investigator's open-label assessment had shown that EC145 plus Doxil significantly improved PFS vs. Doxil alone (5 vs. 2.7 months, p=0.031) (see BioCentury, Jan. 31 & June 20). Per the investigator's assessment, EC145 plus chemotherapy also significantly improved PFS in both subgroups of patients with folate receptor-positive tumors. ...